Transcript Protecting Human Subjects - California State University

Protecting Human
Subjects
Overview of the Issues
Applications to Educational Research
The IRB Process
Why do we need to protect
human subjects?
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Nazi medical experiments
Tuskegee syphilis study
Milgram’s obedience studies
Jessie Gelsinger
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What is research?
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A systematic investigation designed to produce
generalizable knowledge.
Who is a human subject?
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Anyone with whom a researcher obtains identifiable
private information, or anyone with whom a
researcher has contact or receives an intervention.
Who is Responsible?
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Office of Human Research Protections
(OHRP)
Funding Agencies (NIH, DOE, NIJ)
Institutions (IRB)
Researchers
How do IRB’s make
decisions?
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45CFR46 (Federal Regulations)
IRB Policy
Belmont Report
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Justice
Beneficence
Respect for Persons
More on making decisions
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Evaluate the risks
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Physical
Psychological
Social
Minimize the risks
Benefits out weigh the risks
Informed consent
Protect against coercion
 Protection for vulnerable populations (e.g. children)
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Type of IRB Review
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Exempt
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Expedited
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No risk
Still needs an IRB evaluation
Minimal risk
Review by one IRB member
Full review
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Greater than minimal risk
A vote by a convened meeting of the IRB (monthly)
Exempt Research
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Educational Research on commonly accepted
educational practices, conducted as part of the
regular curriculum, as long as no identifiable
information is made public.
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Data taken from individual subjects, as long as
no individual is identifiable.
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Survey and interview procedures, provided
individual subjects are not identifiable, and there
are no other risks.
Exempt Research
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Observations of public behavior if no
identifiable information. For children, must
be no interaction with experimenter.
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Analysis of data that already exists for
other purposes (medical, educational, etc.)
provided no individual is identifiable, or
data are publicly available.
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Evaluation of programs run by the Social
Security Administration or other public
benefit program.
Expedited Review
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Studies involving minimal risk
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No greater than that encountered in daily
activities
No vulnerable populations
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Can only study children under expedited
review if you are the classroom teacher
Full Review of Education Research
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There are greater than minimal risk to
participants
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Vulnerable populations
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No parental consent
Informed Consent
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Standard information required in consent form
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Contact information for you, your supervisor, IRB
Purpose of research
Procedures
Risks to participants
Benefits to participants and to society
Protections (confidentiality, no loss of benefits)
In appropriate language
Informed Consent with Children
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Parental consent
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Child verbal assent if appropriate
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Adolescents can give written assent
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Consent forms translated (and back-translated)
if parents not likely to speak English
Consent Forms
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Consent is a dialog between researcher
and participant, not a piece of paper.
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Form is the documentation of informed
consent.
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Documentation can be waived in special
circumstances.